EMA approval for Pegfilgrastim Mundipharma

Biosimilars/News | Posted 25/10/2019 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.


The drug is a biosimilar of Amgen’s Neulasta (pegfilgrastim), which is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [1].

Pegfilgrastim Mundipharma is produced by Mundipharma Biologics (formerly by Cinfa Biotech), which is part of UK-based Mundipharma International (Mundipharma).

EMA’s approval of Pegfilgrastim Mundipharma is based on data that shows that Pegfilgrastim Mundipharma has comparable quality, safety and efficacy to Neulasta (pegfilgrastim).

EMA’s CHMP has recommended that Pegfilgrastim Mundipharma be approved to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the incidence of febrile neutropenia due to chemotherapy. The CHMP’s opinion will now be reviewed by the European Commission (EC).

Mundipharma also has another pegfilgrastim biosimilar approved in Europe, which it acquired when it bought Spanish biosimilars maker Cinfa Biotech [1]. Pelmeg (B12019) was approved by the EC in November 2018 [2] and launched in Europe in February 2019.

Related article
Biosimilars of pegfilgrastim

1. GaBI Online - Generics and Biosimilars Initiative. Mundipharma buys Spanish biosimilars maker Cinfa Biotech [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 25]. Available from: www.gabionline.net/Pharma-News/Mundipharma-buys-Spanish-biosimilars-maker-Cinfa-Biotech
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EMA, Mundipharma

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